BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE ADVANCE FOR ASTIGMATISM

    MDR report key: 2492198 · Received March 12, 2012

    Report

    Report Number
    1033553-2012-00013
    Event Type
    Injury
    Date Received
    March 12, 2012
    Date of Event
    December 19, 2011
    Report Date
    March 12, 2012
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K032340
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADD'L INFO IS AVAILABLE AT THIS TIME. A LOT HISTORY WAS REQUESTED, THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPEC. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. THE TWO SEALED BLISTERS AND A LENS CASE WERE RETURNED FOR EVAL. THE PARAMETERS OF THE LENSES WERE MEASURED AND A VISUAL INSPECTION WAS PERFORMED. THE LENSES MEET COMPANY STANDARDS FOR BASE CURVE, CENTER THICKNESS, AND DIAMETER. NO VISUAL ATTRIBUTES WERE OBSERVED. IF ADD'L INFO IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN EXECUTIVE MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A STAFF MEMBER AT AN EYE CARE PROFESSIONAL'S (ECP) OFFICE REPORTED THAT A PT WAS DIAGNOSED WITH A CORNEAL ABRASION IN THE RIGHT EYE (OD) AFTER AN ACUVUE ADVANCE FOR ASTIGMATISM BRAND CONTACT LENS TORE IN THE PT'S EYE. ON (B)(6) 2012, THE ECP'S OFFICE FAXED A COMPLETE COPY OF THE PT'S CHART CONTAINING ADD'L INFO. THE CHART INDICATES THAT THE PT PRESENTED ON (B)(6) 2011 "FOR A FU AND AN INFECTION OD" THAT THE PT "HAD ON SATURDAY." THE PT REPORTED THAT THE OD "IMMEDIATELY GOT RED AND IRRITATED" AFTER REMOVING THE CONTACT LENS IN QUESTION FROM THE OD. "THIS MORNING IT WAS MATTED TOGETHER. OS IS FEELING ITCHY, VA NOT RECORDED OU." CONJUNCTIVE: NORMAL OU. CORNEA OD: CORNEAL ABRASION 3MM X 1MM. OS CLEAR. AC: D&Q OU. "I CALLED IN A PRESCRIPTION FOR VIGAMOX YESTERDAY, PT CAN'T AFFORD TO PAY FOR IT." THE PT "DESIRES TO BE PLACED IN TOBRADEX AND IS AWARE THAT IF THE INFECTION GETS WORSE THAT HE/SHE HAS ELECTED NOT TO USE THE BEST ANTIBIOTIC DUE TO FINANCES. " PT HAS NOT BEEN USING RESTASIS DUE TO DISCOMFORT WITH CL WEAR. NO CL WEAR. IMPRESSION: CORNEAL ULCER, UNSPECIFIED OD. TEAR FILM INSUFFICIENCY UNSPECIFIED OU. F/U (B)(6) 2011: CHART INDICATES, "SEEMS TO BE BETTER BUT SENSITIVE TO LIGHT. MEDS EVERY 30 MINUTES AS DIRECTED." UNCORRECTED VA: OD 20/70; OS 20/70. CONJUNCTIVA: NORMAL OU. CORNEA: OD CORNEAL ABRASION LOOSELY ADHERENT EPITHELIUM WITH FILAMENT. OS: CLEAR. AC: D&Q OU. "CORNEAL ULCER OD: THE HAZE HAS IMPROVED THE EPITHELIUM IS OVER THE DEFECT BUT LOOSE. I SUGGESTED THAT THE PT CONTINUE THE TOBRADEX QID OD. RETURN IN 2-3 DAYS FOR FU. TEARS AS NEEDED." IMPRESSION: CORNEAL ULCER, UNSPECIFIED OD. TEAR FILM INSUFFICIENCY UNSPECIFIED OU. F/U (B)(6) 2011: UNCORRECTED VA: OD 20/70; OS 20-60-1. CORNEA OD "LOOSE EPITHELIUM SUP TEMP NO STAIN." OS: CLEAR. "CORNEAL ULCER OD: THE CORNEAL ABRASION HAS HEALED, THE INFILTRATE HAS RESOLVED AND THE EPITHELIUM IS STILL LOOSE. I SUGGESTED THAT THE PT CONTINUE THE TOBRADEX QID OD FOR 3 DAYS THEN D/C. THE PT IS TO RETURN IN 7 DAYS FOR F/U. TEARS AS NEEDED." CALL IF SYMPTOMS WORSEN. NO CL WEAR. IMPRESSION CORNEAL ULCER, UNSPECIFIED OD. TEAR FILM INSUFFICIENTLY UNSPECIFIED OU. F/U (B)(6) 2011: "PT HAS NOT BEEN WEARING CL AND HE NOTICED THIS MORNING THAT BOTH EYES WERE MATTED SHUT THIS AN EYES ARE BOTHERING HIM." UNCORRECTED VA: OU 20/70. CONJUNCTIVA: NORMAL OU. CORNEA: OD NO STAIN EPI INTACT. AC: D&Q OU. THE PT STATES THAT HE/SHE HAS NOT BEEN USING CONTACT LENSES. TOBRADEX 0.3% 1 DROP BID OD. IMPRESSION: CORNEAL ULCER, UNSPECIFIED OD. TEAR FILM INSUFFICIENCY UNSPECIFIED OU. F/U (B)(6) 2011: UNCORRECTED VA OD: NOT NOTED. TEAR FILM: GOOD OU. CONJUNCTIVA: CLEAR OU. CORNEA: OD NO STAIN, EPI INTACT. AC: D&Q OU. IMPRESSION: CORNEAL ULCER OD UNSPECIFIED. TEAR FILM INSUFFICIENCY UNSPECIFIED OU. ONE DROP TOBRADEX BID OD. IMPRESSION: CORNEAL ULCER UNSPECIFIED OD. TEAR FILM INSUFFICIENCY, UNSPECIFIED OU. F/U (B)(6) 2012: UNCORRECTED VA OU: 20/50. TEAR FILM: GOOD FILM: GOOD OU. CORNEA: OD NO STAIN, EPI INTACT. NEG STAIN SUP WITH TRACE HAZE. AC: DEEP AND QUIET OU. RTC IN A FEW DAYS. NO CONTACT LENS WEAR. IMPRESSION: CORNEAL ULCER UNSPECIFIED OD. TEAR FILM INSUFFICIENCY UNSPECIFIED OU. F/U (B)(6) 2012: UNCORRECTED VA: OD 20/20. CONJUNCTIVA OU: NORMAL. CORNEA: OD NO STAIN, EPI INTACT, EPITHELIUM SMOOTH SUPERIORLY WITH MILD HAZE. OK TO STAY OFF THE TOBRADEX. NO CONTACT LENS WEAR FOR ONE MORE WEEK. RETURN IN (B)(6) 2012 FOR A COMPLETE EXAM. IMPRESSION: CORNEAL ULCER UNSPECIFIED OD. TEAR FILM INSUFFICIENCY UNSPECIFIED OU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE ADVANCE FOR ASTIGMATISM SOFT CONTACT LENS LPL VISTAKON NA B00BSLJ0J7

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention